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The safety of agomelatine in standard medical practice in depressed patients: A 26‐week international multicentre cohort study
Author(s) -
Gorwood Philip,
Benichou Jacques,
Moore Nicholas,
Álvarez Martínez Enric,
Mertens Joost,
Aguglia Eugenio,
Figueira MariaLuisa,
Falkai Peter,
Olivier Valérie,
Wattez Marine,
PicarelBlanchot Françoise,
de Bodinat Christian
Publication year - 2021
Publication title -
human psychopharmacology: clinical and experimental
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.461
H-Index - 78
eISSN - 1099-1077
pISSN - 0885-6222
DOI - 10.1002/hup.2759
Subject(s) - agomelatine , medicine , incidence (geometry) , observational study , cohort , cohort study , depression (economics) , adverse effect , clinical global impression , major depressive disorder , prospective cohort study , psychiatry , mood , antidepressant , alternative medicine , physics , macroeconomics , pathology , hippocampus , optics , economics , placebo
Objective The present observational cohort study documented the safety of agomelatine in current medical practice in out‐patients suffering from major depressive disorder. Method The 6‐month evolution of agomelatine‐treated patients was assessed with a focus on safety (emergent adverse events, liver acceptability), severity of depression using the Clinical Global Impression Severity (CGI‐S) score, and functioning measured by the Sheehan Disability Scale (SDS). Results A total of 8453 depressed patients from 761 centres in 6 countries were analysed (female: 67.7%; mean age: 49.1 ± 14.8 years). Adverse events reported were in accordance with the known safety profile of agomelatine. Cutaneous events were reported in 1.7% of the patients and increased hepatic transaminases values were reported in 0.9 % of the patients. The incidence of events related to suicide/self‐injury was 1.0%. Two completed suicides, not related to the study drug, were reported. CGI‐S total scores and SDS sub‐scores improved and numbers of days lost or underproductive decreased over the treatment period. Conclusions In standard medical practice, agomelatine treatment was associated with a low incidence of side effects. No unexpected events were reported. A decrease in the severity of the depressive episode and improved functioning were observed. Trial registration name Observational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients. A prospective, observational (non‐interventional), international, multicentre cohort study. Trial registration number ISRCTN53570733